Epjevy: Withdrawal of the marketing authorisation application

Overview

On 7 February 2019, CTI Life Sciences Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Epjevy, for treating symptoms of myelofibrosis in patients with severe thrombocytopenia.

Key facts

Name
Epjevy
Product number
EMEA/H/C/004793
Date of withdrawal
07/02/2019
Company making the application
CTI Life Sciences Limited
Withdrawal type
Initial authorisation

Related information on withdrawals

A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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